Company faces US legal action over mesh surgery

The company's pelvic mesh is used to treat prolapse.
The company's pelvic mesh is used to treat prolapse.

A COMPANY owned by a former champion Newcastle basketballer, which is fighting deregistration of its pelvic mesh product in Australia, is facing legal action in America from a woman alleging she had been ‘‘injured catastrophically’’ after mesh surgery.

South Australian-based TFS Manufacturing Pty, owned by former Newcastle Falcon and Australian representative player Paul Zadow, received Ohio court documents last week in which a woman is seeking a jury trial following surgery in August 2013.

The woman alleges she was left with permanent injuries because of complications after TFS mesh and anchors were implanted in her pelvis, which included having a section of her small bowel removed. In a civil claim to the Cuyahoga County Court, the woman alleged she was ‘‘not appropriately advised regarding the experimental nature’’ of the company’s ‘‘tissue fixation system’’ for treating prolapse, a complication after childbirth.

She alleged defendants TFS Manufacturing, and the Texas-based firm TFS Surgical (US) Inc, took part in ‘‘aggressive’’ marketing to health care providers, doctors and directly to the public, offering ‘‘exaggerated and misleading expectations’’ of the product’s safety.

‘‘The defendants failed to perform or rely on proper and adequate testing and research in order to determine and evaluate the risks and benefits of the defendants’ pelvic mesh products,’’ the woman alleged in her claim.

In November last year, TFS Manufacturing was one of the first companies to have its mesh product deregistered by Australia’s Therapeutic Goods Administration after it failed to substantiate how its ‘‘tissue fixation system’’ complied with relevant standards.

The company is appealing the decision.

At the time, Mr Zadow told the Newcastle Herald that his company’s product, ‘‘in the hands of skilled surgeons, has brought enormous benefits to many women in Australia and around the world who had suffered from debilitating medical problems associated with their pelvic floor’’.

In her claim, the American woman quoted subsequent action by the Therapeutic Goods Administration’s advertising complaints panel against TFS Manufacturing in Australia, over claims on its website in which it stated its product ‘‘cures prolapse and symptoms’’.

The complaints panel found the material ‘‘contained representations that had not been verified, were not correct and balanced, were likely to arouse unwarranted expectations, and were misleading’’, the woman alleged in her claim.

Regulators in five countries, including Australia and America, have taken action to restrict more than 60 mesh products by some of the world’s leading pharmaceutical companies, after legal action by thousands of women and concerns about the rigour of clinical evidence relied on to allow them on the market.

Mr Zadow and TFS Manufacturing did not respond to emails and messages from the Herald.